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510(k) K050170

FORTOSS VITAL BONE GRAFT SUBSTITUTE by Biocomposites, Ltd. — Product Code LYC

K050170 is an FDA 510(k) premarket notification submitted by Biocomposites, Ltd. for the device "FORTOSS VITAL BONE GRAFT SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on August 26, 2005. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Biocomposites, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2005
Date Received
January 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Synthetic
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Other clearances by Biocomposites, Ltd.

  • K251680 — Biosteon® Screw (February 17, 2026)
  • K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (June 12, 2025)
  • K250521 — NanoBone® SBX Putty ; NanoBone® QD (April 7, 2025)
  • K212721 — Genex Bone Graft Substitute (February 4, 2022)
  • K141830 — STIMULAN KIT, STIMULAN RAPID CURE (January 23, 2015)
  • K082381 — GENEX (November 14, 2008)
  • K082383 — FORTOSS VITAL (September 5, 2008)
  • K073341 — GENEX PUTTY (July 9, 2008)
  • K081428 — MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR (June 20, 2008)
  • K072127 — DOMINATOR (August 31, 2007)

Other clearances for product code LYC

  • K253317 — Cytrans™ Elashield (July 6, 2026)
  • K253883 — Bonalive Maxillofacial (May 14, 2026)
  • K251818 — BONTREE PLUS (March 6, 2026)
  • K244006 — FG Bone Graft M (September 17, 2025)
  • K243745 — FG Bone Graft B (August 29, 2025)
  • K241186 — Synthetic Bone Graft Particulate (February 21, 2025)
  • K213260 — CMFlexTM (December 30, 2022)
  • K202675 — InRoad® Dental Synthetic Bone Graft (March 4, 2022)
  • K201546 — OsOpia Synthetic Bone Void Filler (October 2, 2020)
  • K201051 — Straumann BoneCeramic (September 24, 2020)

FDA data resources